MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-03 for YASARGILL ANEURYSM CLIP APPLIER FE 542, FE 552 manufactured by Aesculap, Ag.
[7355]
Pt found unconscious at residence on 4/5/94 after returning from a mild weightlifting excercise. He was admitted initially at another facility and later transferred to this current facility on 4/6/94. Pt was diagnosed with ruptured anterior communicating artery aneurysm & subarachnoid hemorrhage. During surgery on the same day, upon dissection anad exposure of artery, aneurysm clips were used to occlude aneurysm and associated vessels. Physician reported experiencing difficulty in the release/catch mechanism of several appliers during surgery. One permanent clip was left implanted, & the procedure was completed. Pt regained consciousness on 4/8/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916714-1994-00010 |
| MDR Report Key | 13717 |
| Date Received | 1994-05-03 |
| Date of Report | 1994-04-12 |
| Date of Event | 1994-04-06 |
| Date Facility Aware | 1994-04-07 |
| Report Date | 1994-04-10 |
| Date Added to Maude | 1994-06-03 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YASARGILL ANEURYSM CLIP APPLIER |
| Generic Name | ANEURYSMM CLIP APPLIER |
| Product Code | HCI |
| Date Received | 1994-05-03 |
| Returned To Mfg | 1994-04-08 |
| Model Number | NA |
| Catalog Number | FE 542, FE 552 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 13715 |
| Manufacturer | AESCULAP, AG |
| Manufacturer Address | P.O. BOX 40 78501 TUTTLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 1994-05-03 |